Breath Samples Collection Clinical Trial, for Development of the TERA BioStation T101, Intended for CoV-19 Exhalation Products Detection.

December 20, 2021 updated by: Tera Group

A Single Center, Two Arms, Non-interventional, Breath Samples Collection Clinical Trial, for Development of the TERA Bio Station T101, Intended for SARS-CoV-2 Exhalation Products Detection.

The Sponsor has developed a rapid screening tool intended to determine if the subject tested has COVID-19.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

According to recent scientific literature, the virus infection occurs mainly through the nasal cavity, and therefore, samples of nasal and pharyngeal fluids are expected to be high viral load samples.

The proposed clinical trial is to test the mentioned for potential dominant virus particles absorbance frequencies according to which, it will be possible to perform a statistical analysis of spectral data of infected subjects' samples compared to healthy ones and to examine whether a statistical significance between 'Infected' and 'Healthy' can be demonstrated in terms spectroscopic measurements.

Indication for Use: Rapid detection of the novel SARS-CoV-2 (COVID-19) virus in breath samples.

The study is aimed to collect data in order to assess whether a patient's COVID -19 status can be identified by a unique spectrophotometric pattern.

Study Type

Interventional

Enrollment (Anticipated)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

General:

  1. Male or female subject aged 18 years and above
  2. Subject is able and willing to provide informed consent

  3. Subject is able to complete the breath test.

    Arm A:

  4. Requiring a diagnostic or screening RT-PCR test for COVID-19.

    Arm B:

  5. Positive to COVID-19 in RT-PCR test performed up to 48 hours before screening.

Exclusion Criteria:

  1. Male of female subject under the age of 18.
  2. Subject is unable to provide and informed consent, for any reason.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A
Requiring a diagnostic or screening RT-PCR test for COVID-19.
Device: BioStation T101 and TeraTube
Rapid detection of the novel SARS-CoV-2 (COVID-19) virus in breath samples.
Experimental: Arm B
Positive to COVID-19 in RT-PCR test performed up to 48 hours before screening.
Device: BioStation T101 and TeraTube
Rapid detection of the novel SARS-CoV-2 (COVID-19) virus in breath samples.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Outcome Measure
Time Frame: The collection of an additional samples requiring COVID 19 diagnostic evaluation will take approximately 1 minute from initial collection of the sample
Rate of positive and negative cases in collected breath samples using breath analyzer test compare to PCR results.
The collection of an additional samples requiring COVID 19 diagnostic evaluation will take approximately 1 minute from initial collection of the sample

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tera Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2022

Primary Completion (Anticipated)

June 1, 2022

Study Completion (Anticipated)

August 1, 2022

Study Registration Dates

First Submitted

December 12, 2021

First Submitted That Met QC Criteria

December 12, 2021

First Posted (Actual)

December 17, 2021

Study Record Updates

Last Update Posted (Actual)

January 11, 2022

Last Update Submitted That Met QC Criteria

December 20, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • TERA-COV-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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